Description
I am an accomplished professional with 23 years of experience in Quality Assurance (QA) and Quality Control (QC) within the Pharmaceutical, Biotech (GMP, GDP, GLP) and Medical Device industries. Skilled technical writer, including various reports, investigations, and SOPs. Extensive experience in managing, lot release, QC Microbiology lab, leading the Deviation/CAPA management team, and customer complaint. Expert in QC and QA personnel coaching and on-the-job training. Highly skilled in managing multiple priorities and completing projects on time. Technical expert on a variety of laboratory tests, techniques, and instruments. Experienced in validation and final report review. Expert in batch record review, discrepancy and CAPA management. Extensive experience (active participation) with various regulatory inspections of QC and QA such as FDA, ISO, EMEA, Mexico. Certified ISO Lead Auditor. Expert in EtQ, SAP, TrackWise, SCORE, TOPAS, LMS, and LIMS. professional with 23 years of experience in Quality Assurance (QA) and Quality Control (QC) within the Pharmaceutical, Biotech (GMP, GDP, GLP) and Medical Device industries. Skilled technical writer, including various reports, investigations, and SOPs. Extensive experience in managing, lot release, QC Microbiology lab, leading the Deviation/CAPA management team, and customer complaint. Expert in QC and QA personnel coaching and on-the-job training. Highly skilled in managing multiple priorities and completing projects on time. Technical expert on a variety of laboratory tests, techniques, and instruments. Experienced in validation and final report review. Expert in batch record review, discrepancy and CAPA management. Extensive experience (active participation) with various regulatory inspections of QC and QA such as FDA, ISO, EMEA, Mexico. Certified ISO Lead Auditor. Expert in EtQ, SAP, TrackWise, SCORE, TOPAS, LMS, and LIMS.
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| (Confidential) | Supervisor Quality Assurance, Product Release | 1/2019 - Present |
| Bio Rad Laboratories | Lead/Senior Quality Assurance, Product Release And Discrepancy Management | 1/2014 - 1/2018 |
| Novartis Pharmaceuticals | Lead/Senior Quality Assurance | 1/2013 - 1/2014 |
| Bayer Health Care | Lead/Senior Quality Control Lead/Senior Quality Assurance | 1/2012 - 1/2013 |
| Chiron/Novartis Corporation/Bayer Health Care | Supervisor Quality Control, Microbiology | 1/2004 - 1/2009 |
| Chiron Corporation | Specialist Quality Control, Microbiology | 1/2001 - 1/2004 |
Accomplishments
Highlights:
Companies I like:
Lonza
Keywords
